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Irinotecan PIL - UK+IRL - Accord (Release Site: Bordon) Phase-2

PACKAGE LEAFLET: INFORMATION FOR THE USER

Irinotecan Hydrochloride 20 mg/ml Concentrate for Solution for Infusion

Irinotecan Hydrochloride Trihydrate

Read all of this leaflet carefully before you start using this medicine.

•    Keep this leaflet. You may need to read it again.

•    If you have any further questions, ask your doctor.

•    This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

•    If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.

In this leaflet:

1.    What Irinotecan Hydrochloride is and what it is used for

2.    Before you use Irinotecan Hydrochloride

3.    How to use Irinotecan Hydrochloride

4.    Possible side effects

5.    How to store Irinotecan Hydrochloride

6.    Further information

1.    What Irinotecan Hydrochloride is and what it is used for

Irinotecan Hydrochloride belongs to a group of medicines called cytostatics (anti-cancer medicines). Irinotecan Hydrochloride is used for the treatment of advanced cancer of the colon and rectum in adults, either in a combination with other medicines or alone.

2.    Before you use Irinotecan Hydrochloride Do not use Irinotecan Hydrochloride if you

•    are allergic (hypersensitive) to Irinotecan Hydrochloride Trihydrate or any of the other ingredients of Irinotecan

•    have or had chronic inflammatory bowel disease or bowel obstruction

•    are pregnant or breast feeding or if you think you might be pregnant

•    have increased levels of bilirubin in the blood (more than 3 times the upper limit of normal)

•    have severe bone marrow failure

•    are in a poor general health (evaluated by a international standard)

•    are using natural remedy St John’s Wort (hypericum perforatum)

Take special care with Irinotecan Hydrochloride

As Irinotecan Hydrochloride is an anti-cancer medicine it will be administered to you in a special unit and under the supervision of a doctor qualified in the use of anti cancer medicines. The unit’s personnel will explain to you what you need to take special care of during and after the treatment. This leaflet helps you to remember that. If you are elderly, your dose may be adjusted depending on your general health. You will be monitored closely during your treatment.

Before treatment with Irinotecan Hydrochloride tell your doctor if any of the following apply to you:

•    You have liver problems or jaundice

•    You have kidney problems

•    You have asthma

•    You have ever received radiation therapy

•    You experienced severe diarrhoea or fever after being treated with Irinotecan before.

•    You have heart problems

•    You smoke, have high blood pressure or high cholesterol as these can increase the risk of heart problems during treatment with Irinotecan

•    You have had or are due to have any vaccinations

•    You are taking any other medicines. Please see the section below “Taking other medicines”.

1)    The first 24 hours after administration of Irinotecan

During administration of Irinotecan (30 - 90 min.) and shortly after administration you may experience some of the following symptoms:

•    Diarrhoea    •    Watering eyes

•    Sweating    •    Visual disturbance

•    Abdominal pain    •    Excessive mouth watering

The medical term for these symptoms is acute cholinergic syndrome, which can be treated (with atropine). If you have any of these symptoms immediately tell your doctor who will give you any treatment necessary.

2)    From day after treatment with Irinotecan Hydrochloride until next treatment.

During this period you may experience various symptoms, which may be serious and require immediate treatment and close supervision.

Diarrhoea

If your diarrhoea starts more than 24 hours after administration of Irinotecan Hydrochloride (“delayed diarrhoea”) it may be serious. It is often seen about 5 days after administration. The diarrhoea should be treated immediately and kept under close supervision. Immediately after the first liquid stools do the following:

1.    Take any anti-diarrhoeal treatment that the doctor has given you, exactly as he/she has told you. The treatment may not be changed without consulting the doctor. Recommended anti diarrhoeal treatment is loperamide (4 mg for the first intake and then 2 mg every 2 hours, also during the night). This should be continued for at least 12 hours after the last liquid stools. The recommended dosage of loperamide may not be taken for more than 48 hours.

2.    Drink large amounts of water and rehydration fluids immediately (i.e. water, soda water, fizzy drink, soup or oral rehydration therapy).

3.    Immediately inform your doctor who is supervising the treatment and tell him/her about the diarrhoea. If you are not able to reach the doctor contact the unit at the hospital supervising the Irinotecan Hydrochloride treatment. It is very important that they are aware of the diarrhoea

You must immediately tell the doctor, or the unit supervising the treatment, if

•    You have nausea, vomiting or any fever as well as diarrhoea

•    You still have diarrhoea 48 hours after starting the diarrhoea treatment

Note: Do not take any treatment for diarrhoea other than that given to you by your doctor and the fluids described above. Follow the doctor’s instruction. The anti-diarrhoeal treatment should not be used to prevent a further episode of diarrhoea. Even though you have experienced delayed diarrhoea at previous cycles.

Fever

If the body temperature increases over 38°C it may be a sign of infection, especially if you also have diarrhoea. If you have any fever (over 38°C) contact your doctor or the unit immediately so that they can give you any treatment necessary.

Nausea and vomiting

If you have nausea and/or vomiting contact your doctor or the unit immediately.

Neutropenia

Irinotecan Hydrochloride may cause a decrease in the number of some of your white blood cells, which play an important role in fighting infections. This is called neutropenia. Neutropenia is often seen during treatment with Irinotecan and is reversible. Your doctor should arrange for you to have regular blood tests to monitor these white blood cells. Neutropenia is serious and should be treated immediately and carefully monitored.

Breathing difficulties

If you have any breathing difficulties contact your doctor immediately. Patients with liver problems

Before treatment with Irinotecan Hydrochloride is started and before every following treatment cycle the liver function should be monitored (by blood tests).

If you have one or more of the symptoms mentioned, after you have returned home from the hospital, you should immediately contact the doctor or the unit supervising the Irinotecan Hydrochloride treatment.

Patients with kidney problems

As this medicine has not been tested in patients with kidney problems, please check with your doctor if you have any kidney problem.

Radiation therapy

Before treatment with Irinotecan Hydrochloride, tell your doctor, if you have ever received radiation therapy.

Vaccinations

Before treatment with Irinotecan Hydrochloride, tell your doctor, if you have had or are due to have any vaccinations.

Using other medicines

Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. This is also valid for herbal medicines, strong vitamins and minerals.

If you receive Irinotecan in combination with either capecitabine, cetuximab or bevacizumab, please make sure that you also read the patient information leaflet for each medicine.

Some medicines may alter the effects of Irinotecan Hydrochloride e.g. ketoconazole (for the treatment of fungal infections), rifampicin (for the treatment of tuberculosis), warfarin (an anticoagulant used to thin the blood), atazanavir (used to treat HIV), ciclosporin or tacrolimus (used to dampen down your body’s immune system) and some medicines for the treatment of epilepsy (carbamazepine, phenobarbital and phenytoin). The herbal medicine St John’s Wort (hypericum perforatum) may not be used concurrent with Irinotecan Hydrochloride and not between treatments, as it may decrease the effect of Irinotecan.

If you require an operation, please tell your doctor or anesthetist that you are using this medicine, as it may alter the affect of some medicines used during surgery.

Pregnancy and breast-feeding

Irinotecan Hydrochloride must not be used during pregnancy. Irinotecan can cause birth defects.

Women of child-bearing age should avoid becoming pregnant. Contraceptive measures must be taken by both male and female patients during and for at least three months (by males) and one month (by females) after cessation of therapy. Still, if you become pregnant during this period you must immediately inform your doctor.

Breast feeding must be discontinued for the duration of Irinotecan Hydrochloride therapy.

Ask your doctor for advice before taking any medicine.

Driving and using machines

In some cases Irinotecan Hydrochloride may cause side effects, which affect the ability to drive and use tools and machines. Contact your doctor if you are unsure.

During the first 24 hours after administration of Irinotecan you may feel dizzy or have visual disturbances. If this happens to you do not drive or use any tools or machines.

Important information about some of the ingredients of Irinotecan Hydrochloride

Irinotecan contains sorbitol. If you suffer from intolerance to some sugars, tell your doctor before you are given this medicinal product.

3. How to use Irinotecan Hydrochloride

Irinotecan Hydrochloride will be given as an infusion into your veins over a period of 30 to 90 minutes.

The amount of infusion you are given will depend on your age, size and general medical condition. It will also depend on any other treatment you may have received for your cancer. Your doctor will calculate your body surface area in square meters (m²).

•    If you have previously been treated with 5-fluorouracil you will normally be treated with Irinotecan Hydrochloride alone starting with a dose of 350 mg/m² every 3 weeks.

•    If you have not had previous chemotherapy you will normally receive 180 mg/m² Irinotecan Hydrochloride every two weeks. This will be followed by folinic acid and 5-fluorouracil.

•    If you are treated with irinotecan in combination with cetuximab you will normally receive the same dose of irinotecan as administered in the last cycles of the prior irinotecan containing regimen. Irinotecan Hydrochloride must not be administered earlier than 1 hour after the end of the cetuximab infusion

These dosages may be adjusted by your doctor depending on your condition and any side effects you may have.

If you receive more Irinotecan Hydrochloride than you should

It is unlikely that you will be given too much Irinotecan Hydrochloride. However in the event that this occurs you may have some severe blood disorders and diarrhoea. Maximum supportive care should be taken to prevent dehydration due to diarrhoea and to treat any infectious complications. You should talk to the doctor administering your medicine.

If you miss a dose of Irinotecan Hydrochloride

It is very important to receive all scheduled doses. If you miss a dose, contact your doctor promptly.

If you stop using Irinotecan Hydrochloride

Do not stop medicine without doctor or pharmacist approval.

Irinotecan PIL - UK+IRL - Accord

iiiii

PACKAGE LEAFLET: INFORMATION FOR THE USER Irinotecan Hydrochloride 20 mg/ml Concentrate for Solution for Infusion

Irinotecan Hydrochloride Trihydrate

Read all of this leaflet carefully before you start using this medicine.

•    Keep this leaflet. You may need to read it again.

•    If you have any further questions, ask your doctor.

•    This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

•    If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.

In this leaflet:

1.    What Irinotecan Hydrochloride is and what it is used for

2.    Before you use Irinotecan Hydrochloride

3.    How to use Irinotecan Hydrochloride

4.    Possible side effects

5.    How to store Irinotecan Hydrochloride

6.    Further information

1.    What Irinotecan Hydrochloride is and what it is used for

Irinotecan Hydrochloride belongs to a group of medicines called cytostatics (anti-cancer medicines). Irinotecan Hydrochloride is used for the treatment of advanced cancer of the colon and rectum in adults, either in a combination with other medicines or alone.

2.    Before you use Irinotecan Hydrochloride Do not use Irinotecan Hydrochloride if you

•    are allergic (hypersensitive) to Irinotecan Hydrochloride Trihydrate or any of the other ingredients of Irinotecan

•    have or had chronic inflammatory bowel disease or bowel obstruction

•    are pregnant or breast feeding or if you think you might be pregnant

•    have increased levels of bilirubin in the blood (more than 3 times the upper limit of normal)

•    have severe bone marrow failure

•    are in a poor general health (evaluated by a international standard)

•    are using natural remedy St John’s Wort (hypericum perforatum)

Take special care with Irinotecan Hydrochloride

As Irinotecan Hydrochloride is an anti-cancer medicine it will be administered to you in a special unit and under the supervision of a doctor qualified in the use of anti cancer medicines. The unit’s personnel will explain to you what you need to take special care of during and after the treatment. This leaflet helps you to remember that. If you are elderly, your dose may be adjusted depending on your general health. You will be monitored closely during your treatment.

Before treatment with Irinotecan Hydrochloride tell your doctor if any of the following apply to you:

You have liver problems or jaundice You have kidney problems You have asthma

You have ever received radiation therapy

You experienced severe diarrhoea or fever after being treated with Irinotecan before.

You have heart problems

You smoke, have high blood pressure or high cholesterol as these can increase the risk of heart problems during treatment with Irinotecan You have had or are due to have any vaccinations

You are taking any other medicines. Please see the section below “Taking other medicines”.

1) The first 24 hours after administration of Irinotecan

During administration of Irinotecan (30 - 90 min.) and shortly after administration you may experience some of the following symptoms:

•    Diarrhoea    •    Watering eyes

•    Sweating    •    Visual disturbance

•    Abdominal    pain    •    Excessive mouth watering

The medical term for these symptoms is acute cholinergic syndrome, which can be treated (with atropine). If you have any of these symptoms immediately tell your doctor who will give you any treatment necessary.

Irinotecan Hydrochloride 20 mg/ml Concentrate for Solution for Infusion

The following information is intended for medical or healthcare professionals only:

Instructions for use - Cytotoxic Handling of Irinotecan Hydrochloride

As with other neoplastic agents, caution should be exercised when handling Irinotecan. Dilution should be carried out under aseptic conditions by trained personnel in a designated area. Precautions should be taken to avoid contact with the skin and mucous membranes.

2) From day after treatment with Irinotecan Hydrochloride until next treatment.

During this period you may experience various symptoms, which may be serious and require immediate treatment and close supervision.

Diarrhoea

If your diarrhoea starts more than 24 hours after administration of Irinotecan Hydrochloride (“delayed diarrhoea”) it may be serious. It is often seen about 5 days after administration. The diarrhoea should be treated immediately and kept under close supervision. Immediately after the first liquid stools do the following:

1.    Take any anti-diarrhoeal treatment that the doctor has given you, exactly as he/she has told you. The treatment may not be changed without consulting the doctor. Recommended anti diarrhoeal treatment is loperamide (4 mg for the first intake and then 2 mg every 2 hours, also during the night). This should be continued for at least 12 hours after the last liquid stools. The recommended dosage of loperamide may not be taken for more than 48 hours.

2.    Drink large amounts of water and rehydration fluids immediately (i.e. water, soda water, fizzy drink, soup or oral rehydration therapy).

3.    Immediately inform your doctor who is supervising the treatment and tell him/her about the diarrhoea. If you are not able to reach the doctor contact the unit at the hospital supervising the Irinotecan Hydrochloride treatment. It is very important that they are aware of the diarrhoea

You must immediately tell the doctor, or the unit supervising the treatment, if

•    You have nausea, vomiting or any fever as well as diarrhoea

•    You still have diarrhoea 48 hours after starting the diarrhoea treatment

Note: Do not take any treatment for diarrhoea other than that given to you by your doctor and the fluids described above. Follow the doctor’s instruction. The anti-diarrhoeal treatment should not be used to prevent a further episode of diarrhoea. Even though you have experienced delayed diarrhoea at previous cycles.

Fever

If the body temperature increases over 38°C it may be a sign of infection, especially if you also have diarrhoea. If you have any fever (over 38°C) contact your doctor or the unit immediately so that they can give you any treatment necessary.

Nausea and vomiting

If you have nausea and/or vomiting contact your doctor or the unit immediately.

Neutropenia

Irinotecan Hydrochloride may cause a decrease in the number of some of your white blood cells, which play an important role in fighting infections. This is called neutropenia. Neutropenia is often seen during treatment with Irinotecan and is reversible. Your doctor should arrange for you to have regular blood tests to monitor these white blood cells. Neutropenia is serious and should be treated immediately and carefully monitored.

Breathing difficulties

If you have any breathing difficulties contact your doctor immediately. Patients with liver problems

Before treatment with Irinotecan Hydrochloride is started and before every following treatment cycle the liver function should be monitored (by blood tests).

If you have one or more of the symptoms mentioned, after you have returned home from the hospital, you should immediately contact the doctor or the unit supervising the Irinotecan Hydrochloride treatment.

Patients with kidney problems

As this medicine has not been tested in patients with kidney problems, please check with your doctor if you have any kidney problem.

Radiation therapy

Before treatment with Irinotecan Hydrochloride, tell your doctor, if you have ever received radiation therapy.

Vaccinations

Before treatment with Irinotecan Hydrochloride, tell your doctor, if you have had or are due to have any vaccinations.

Using other medicines

Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. This is also valid for herbal medicines, strong vitamins and minerals.

Protection instructions for preparation of Irinotecan Hydrochloride solution for infusion

1.    Protective chamber should be used and protective gloves as well as protective gown should be worn. If there is no protective chamber available mouth cover and goggles should be used.

2.    Opened containers, like injection vials and infusion bottles and used cannulae, syringes, catheters, tubes, and residuals of cytostatics should be considered as hazardous waste and undergo disposal according to local guidelines for the handling of HAZARDOUS WASTE.

If you receive Irinotecan in combination with either capecitabine, cetuximab or bevacizumab, please make sure that you also read the patient information leaflet for each medicine.

Some medicines may alter the effects of Irinotecan Hydrochloride e.g. ketoconazole (for the treatment of fungal infections), rifampicin (for the treatment of tuberculosis), warfarin (an anticoagulant used to thin the blood), Atazanavir (used to treat HIV), ciclosporin or tacrolimus (used to dampen down your body’s immune system) and some medicines for the treatment of epilepsy (carbamazepine, phenobarbital and phenytoin).

The herbal medicine St John’s Wort (hypericum perforatum) may not be used concurrent with Irinotecan Hydrochloride and not between treatments, as it may decrease the effect of Irinotecan.

If you require an operation, please tell your doctor or anesthetist that you are using this medicine, as it may alter the affect of some medicines used during surgery.

Pregnancy and breast-feeding

Irinotecan Hydrochloride must not be used during pregnancy. Irinotecan can cause birth defects.

Women of child-bearing age should avoid becoming pregnant. Contraceptive measures must be taken by both male and female patients during and for at least three months (by males) and one month (by females) after cessation of therapy. Still, if you become pregnant during this period you must immediately inform your doctor.

Breast feeding must be discontinued for the duration of Irinotecan Hydrochloride therapy.

Ask your doctor for advice before taking any medicine.

Driving and using machines

In some cases Irinotecan Hydrochloride may cause side effects, which affect the ability to drive and use tools and machines. Contact your doctor if you are unsure.

During the first 24 hours after administration of Irinotecan you may feel dizzy or have visual disturbances. If this happens to you do not drive or use any tools or machines.

Important information about some of the ingredients of Irinotecan Hydrochloride

Irinotecan contains sorbitol. If you suffer from intolerance to some sugars, tell your doctor before you are given this medicinal product.

3. How to use Irinotecan Hydrochloride

This medicine is intended for adults only.

Irinotecan Hydrochloride will be given as an infusion into your veins over a period of 30 to 90 minutes.

The amount of infusion you are given will depend on your age, size and general medical condition. It will also depend on any other treatment you may have received for your cancer. Your doctor will calculate your body surface area in square meters (m²).

•    If you have previously been treated with 5-fluorouracil you will normally be treated with Irinotecan Hydrochloride alone starting with a dose of 350 mg/m² every 3 weeks.

•    If you have not had previous chemotherapy you will normally receive 180 mg/m² Irinotecan Hydrochloride every two weeks. This will be followed by folinic acid and 5-fluorouracil.

•    If you are treated with irinotecan in combination with cetuximab you will normally receive the same dose of irinotecan as administered in the last cycles of the prior irinotecan containing regimen. Irinotecan Hydrochloride must not be administered earlier than 1 hour after the end of the cetuximab infusion

These dosages may be adjusted by your doctor depending on your condition and any side effects you may have.

If you receive more Irinotecan Hydrochloride than you should

It is unlikely that you will be given too much Irinotecan Hydrochloride. However in the event that this occurs you may have some severe blood disorders and diarrhoea. Maximum supportive care should be taken to prevent dehydration due to diarrhoea and to treat any infectious complications. You should talk to the doctor administering your medicine.

If you miss a dose of Irinotecan Hydrochloride

It is very important to receive all scheduled doses. If you miss a dose, contact your doctor promptly.

If you stop using Irinotecan Hydrochloride

Do not stop medicine without doctor or pharmacist approval.

3. Follow the instructions below in case of spillage:

•    protective clothing should be worn

•    broken glass should be collected and placed in the container for HAZARDOUS WASTE.

•    contaminated surfaces should be flushed properly with copious amount of cold water

•    the flushed surfaces should then be wiped thoroughly and the materials used for wiping should be disposed as HAZARDOUS WASTE

llll

If you have any further questions on the use of this product, ask your doctor.

4. Possible side effects

Like all medicines, Irinotecan Hydrochloride can cause side effects, although not everybody gets them. Your doctor will discuss these side effects with you and explain the risks and benefits of your treatment. Some of these side effects must be treated immediately.

See also information in section “Take special care with Irinotecan Hydrochloride ”

Tell your doctor immediately if you notice any of the following:

-    Allergic reactions including breating difficulties, rash or itching, dizziness or anaphylactic/anaphylactoid reactions

-    If your diarrhoea starts less than 24 hours after the infusion (“early diarrhoea”).

-    If your diarrhoea starts more than 24 hours after the infusion (“delayed diarrhoea”).

-    Fever, nausea and vomiting.

Very common side effects (more than 1 in 10 patients

•    Blood disorder: Neutropenia (decreased number of some white blood cells), thrombocytopenia (decreased number of blood platelets), anaemia

•    Delayed diarrhoea

•    Nausea and vomiting

•    Hair loss (the hair grows again after end of treatment)

•    In combination therapy transient serum levels of some enzymes (ALT, AST, alkaline phosphatase) or bilirubin

Common side effects (less than 1 in 10 patients):

•    Acute cholinergic syndrome: the main symptoms are defined as early diarrhoea and various other symptoms such as abdominal pain, red, sore, itching and weeping eyes (conjunctivitis); running nose (rhinitis); low blood pressure; widening of the blood vessels; sweating, chills; a feeling of general discomfort and illness, dizziness; visual disturbance, pupil contraction; watering eyes and increased salivation, occurring during or within the first 24 hours after the infusion of Irinotecan Hydrochloride

•    Fever, infections (including sepsis - a serious infection that can affect the whole body.)

•    Fever associated with a severe decrease in the number of some white blood cells

•    Dehydration, commonly associated with diarrhoea and/or vomiting.

•    Constipation

•    Fatigue

•    Increased level of liver enzymes and creatinine in the blood.

Uncommon side effects (less than 1 in 100 patients):

•    Allergic reactions

•    Mild skin reactions; mild reactions at the infusion site

•    Early effects such as breathing difficulties

•    Lung disease (interstitial pulmonary disease)

•    Intestinal blockage

•    Abdominal pain and inflammation, causing diarrhoea (a condition known as pseudomambraneous colitis)

•    Infrequent cases of kidney problems, low blood pressure or cardio-circulatory failure have been observed in patients who experienced episodes of dehydration associated with diarrhoea and/or vomiting or sepsis.

Rare side effects (less than 1 in 1000 patients):

•    Severe allergic reactions (anaphylactic/anaphylactoid reactions). If this happens you should tell your doctor immediately

•    Early effects such as muscular contraction or cramps and numbness (paraesthesia).

•    Gastrointestinal bleeding and inflammation of the colon including the appendix

•    Intestinal perforation; anorexia; abdominal pain; inflammation of mucous membranes

•    Inflammation of pancreas

•    Increased blood pressure during and following administration.

•    Decreased levels of potassium and sodium in the blood, mostly related to diarrhoea and vomiting

Very rare side effects (less than 1 in 10,000 patients):

•    Transient speech disorders

•    Increase in levels of some digestive enzymes, which break down sugars and fats.

4.    In the event of Irinotecan Hydrochloride contact with the skin, the area should be rinsed with plenty of running water and then washed with soap and water. In case of contact with mucous membranes, wash the contacted area thoroughly with water. If you have any discomfort, contact doctor.

5.    In case of contact of Irinotecan Hydrochloride with eyes wash them thoroughly with plenty of water. Contact an ophthalmologist immediately.

Preparation for the infusion solution

Irinotecan Hydrochloride concentrate for solution for infusion is intended

If you receive Irinotecan Hydrochloride in combination with cetuximab, some of the side effects you may experience can also be related to this combination. Such side effects may include a acne- like rash. Therefore, please make sure that you also read the package leaflet for cetuximab.

If you receive Irinotecan Hydrochloride in combination with capecitabine, some of the side effects you may experience can also be related to this combination. Such side effects may include: very common blood clots, common allergic reactions, heart attack and fever in patients with a low white blood cell count. Therefore, please make sure that you also read the package leaflet for capecitabine.

If you receive Irinotecan Hydrochloride in combination with capecitabine and bevacizumab, some of the side effects you may experience can also be related to this combination. Such side effects include: low white blood cell count, blood clots, high blood pressure and heart attack. Therefore, please make sure that you also read the package leaflet for capecitabine and bevacizumab.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. By reporting side effects you can help provide more information on the safety of this medicine. For UK - You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard

For Ireland - Reports may be made by following the links to the online reporting option accessible from the IMB homepage, or by completing the downloadable report form also accessible from the IMB website, which may be completed manually and submitted to the IMB via freepost, to the following address:

FREEPOST

Pharmacovigilance Section Irish Medicines Board Kevin O’Malley House Earlsfort Centre Earlsfort Terrace Dublin 2

Tel: +353 1 6764971 Fax: +353 1 6762517 Website: www.imb.ie(http://www.imb.ie) e-mail: imbpharmacovigilance@imb.ie

5.    How to store Irinotecan Hydrochloride

Keep out of the reach and sight of children.

Do not freeze.

For single use only.

Store below 25°C. Store in the original package in order to protect from light. Do not use this medicinal product after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month.

The product should be diluted and used immediately after opening.

If prepared aseptically, the diluted solution can be stored for 24 hours at temperature up to 15-25°C and for 48 hours at 2-8°C (e.g. in a fridge).

From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8°C, unless reconstitution / dilution (etc) has taken place in controlled and validated aseptic conditions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6.    Further information

What Irinotecan Hydrochloride 20 mg/ml Concentrate for Solution for Infusion contains:

•    The active substance is Irinotecan Hydrochloride Trihydrate.

•    1 ml of concentrate contains 20 mg irinotecan hydrochloride trihydrate equivalent to 17.33 mg of irinotecan.

•    One 2 ml vial contains 40 mg irinotecan hydrochloride trihydrate

•    One 5 ml vial contains 100 mg irinotecan hydrochloride trihydrate

•    One 15 ml vial contains 300 mg irinotecan hydrochloride trihydrate

•    One 25 ml vial contains 500 mg irinotecan hydrochloride trihydrate

•    The other ingredients are sorbitol E420, lactic acid, sodium hydroxide, hydrochloric acid and water for injections.

for intravenous infusion only after diluting prior to administration in the recommended diluents, either 0.9 % Sodium chloride solution for infusion or 5% glucose solution for infusion. Aseptically withdraw the required amount of Irinotecan Hydrochloride concentrate for solution from the vial with a calibrated syringe and inject into a 250 ml infusion bag or bottle. The infusion should be thoroughly mixed by manual rotation.

If any precipitate is observed in the vials or after reconstitution, the product should be discarded according to standard procedure for cytotoxic agents. Irinotecan Hydrochloride should not be delivered as an intravenous bolus or

What Irinotecan Hydrochloride 20 mg/ml Concentrate for Solution for Infusion looks like and contents of the pack:

Irinotecan Hydrochloride 20 mg/ml Concentrate for Solution for Infusion is a clear, pale yellow coloured solution.

Pack size:

1x 2 ml vial or 1 x 5 ml vial or 1 x 15 ml vial or 1 x 25 ml vial Not all pack sizes may be marketed

Marketing authorisation holder:

Fresenius Kabi Oncology Plc Lion Court, Farnham Road, Bordon Hampshire, GU35 0NF, United Kingdom

Manufacturers:

Accord Healthcare Limited, Sage House, 319 Pinner Road, North Harrow, HA1 4HF, UK

This medicinal product is authorized in the member states of the EEA under the following names:

Austria	Irinotecan Fresenius 20 mg/ml Konzentrat zur Herstellung einer Infusionslosung
Belgium	Irinokabi 20 mg/ml concentraat voor oplossing voor infusie
Czech Republic	Irinotecan Fresenius 20 mg/ml koncentrat pro infuzm roztok
Germany	Irinotecan Fresenius 20 mg/ml Konzentrat zur Herstellung einer Infusionslosung
Denmark	Irinokabi
Estonia	Irinotecan Fresenius
Spain	Irinotecan Fresenius 20 mg/ml concentrado para solucion para perfusion EFG
Hungary	Irinotecan Fresenius 20 mg/ml koncentratum oldatos infuziohoz
Ireland	Irinotecan Hydrochloride 20 mg/ml concentrate for solution for infusion
Italy	Irinotecan Fresenius
Latvia	Irinotecan Fresenius 20 mg/ml koncentrats infuziju sklduma pagatavosanai
Lithuania	Irinotecan Fresenius 20 mg/ml koncentratas infuziniam tirpalui
The Netherlands	Irinotecan HCl-trihydraat Fresenius Kabi 20 mg/ml concentraat voor oplossing voor infusie
Norway	Irinokabi 20 mg/ml konsentrat til infusjonsv$ske
Poland	Irinotecan Fresenius
Portugal	Irinotecano Fresenius
Sweden	Irinokabi 20 mg/ml, koncentrat till infusionsvatska, losning
Slovak Republic	Irinotecan Fresenius 20 mg/ml infuzny koncentrat
United Kingdom	Irinotecan Hydrochloride 20 mg/ml concentrate for solution for infusion

The leaflet was last revised in 11/2014.

x

an intravenous infusion shorter than 30 minutes or longer than 90 minutes. Disposal

All items used for preparation, administration or otherwise coming into contact with Irinotecan Hydrochloride should undergo disposal according to local guidelines for the handling of cytotoxic compounds.

Last Modified: 27 November 2014 3:14 PM

Fresenius Kabi

Irinotecan Fresenius 20 mg/ml UK/IRL

300 x 300 mm (PIL)

Times New Roman 8 pt. Accord (Intas)

01

Third party code “10 0000 0 000000”

&/or Pharma code will be placed & checked by Accord (Intas) at their end.